Impact factor: 3.958/ICV: 4.10 ISSN: REVIEW ARTICLE ON MEDICATED LOLLIPOP Kalpesh Patil*, Namrata Patil, S.A.Tadvi, S.P.

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1 Impact factor: 3.958/ICV: 4.10 ISSN: Pharma Science Monitor 8(2), Apr-Jun 2017 PHARMA SCIENCE MONITOR AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES Journal home page: REVIEW ARTICLE ON MEDICATED LOLLIPOP Kalpesh Patil*, Namrata Patil, S.A.Tadvi, S.P.Pawar P. S.G. V. P. Mandal s College Of Pharmacy, Shahada(MH). ABSTRACT There are several dosage forms in the market, there is a need for more dosage form which acts effectively and locally as well as systematically. The benefits of the present research work is increased retention time of the dosage form in oral cavity and increased bioavailability, reduction in gastric irritation by passing first pass metabolism. Lollipops are flavored medicated dosage form intended to be sucked and held in the mouth or pharynx containing one or more medicaments usually in the sweetened base. The conventional dosage forms like tablets, capsules, syrups etc are inconvenient for paediatric patients because of difficult to swallow tablets and capsules or unpleasant taste of drug. As a result, the demand for developing new technologies has been increasing day by day. Medicated lollipop is designed to improve patient compliance, acceptability and increase oral retention time. The lollipops were prepared by heating and congealing method using polymer. Lollipops are available in a number of colors and flavors, particularly fruit flavors. Flavored lollipops containing medicine are intended to give children medicine without fuss. KEYWORDS: Medicated lollipop, flavored medicated dosage form, heating and congealing method. INTRODUCTION Lollipops are solid dosage forms, containing medicament in a sweetened & flavored base, intended to dissolve slowly in the mouth. Lollipops are mainly contained sweetening agent flavoring agent, coloring agent, opacifiers & stabilizing agent. Lollipops are the flavored medicated dosage forms intended to be sucked and held in the mouth or pharynx containing one or more medicaments usually in the sweetened base.lollipop are intended to relieve oropharyngeal symptoms, which are commonly caused by local infections and also for systemic effect provided the drug is well absorbed through the buccal linings or when it is swallowed. Lollipop are used for patients who cannot swallow solid oral dosage forms as well as for medications designed to be released slowly to yield a constant level of drug in the oral cavity or to bathe the throat tissues in a solution of the Drugs often incorporated into Lollipop include analgesics, anesthetics, antimicrobials, antidepressants, antiseptics, antitussives, aromatics, astringents, corticosteroids, decongestants, and demulcents. However, this is by no means an exhaustive list as many other drugs may lend themselves to delivery by a Lollipop. As well, both

2 Impact factor: 3.958/ICV: 4.10 ISSN: single and multi ingredient Lollipops can be compounded, depending on the particular patient's needs 1. Oral administration is the most popular route due to ease of ingestion, pain avoidance and most importantly patient compliance. Traditional tablets and capsules are inconvenient for paediatric patients because of difficult to swallow it or unpleasant taste of liquid dosage forms. Since from past decade, there has been an increased demand for more patient-friendly and compliant dosage forms. As a result, the demand for developing new technologies has been increasing day by day 2. General consideration for designing medicated lollipop 3 :- Since the development cost of a new chemical entity is very high, the pharmaceutical companies are now focusing on the development of new drug delivery systems for existing drug with an improved efficacy and bioavailability together with reduced dosing frequency to minimize side effects Typically, oral candidacies takes the form of an adherent white, curd like, circumscribed plaque anywhere within the oral cavity. There are many drugs dosage forms like lozenges, tablets, inhalers, and syrups, are in markets for the treatment of the same. These preparations are commonly used for the purpose of local effect or systemic effect. New drug design to this area always benefit for the patient, physician and drug industry. There are several dosage forms like in the market; there is a need for more dosage forms which acts effectively and locally as well as systematically. ADVANTAGES OF MEDICATED LOLLIPOPS 4 : Having formulas that are easy to change and can be patient specific. It has a pleasant taste and it extends the time that a quantity of drug remains in the oral cavity to elicit a therapeutic effect also, pharmacist can prepare lollipops extemporaneously with minimal equipment and time. Lollipops can be given to those patients who have difficulty in swallowing. It extends the time of drug in the oral cavity to elicit a specific effect. Easy to prepare with minimum amount of equipment and time Do not require water intake for administration. Technique is non-invasive, as is the case with parenteral. DISADVANTAGES OF MEDICATED LOLLIPOPS 4 : Heat labile drugs cannot be used in this formulation because of the high temperatures required for preparation. Drugs having minimum bitter taste are suitable.

3 Impact factor: 3.958/ICV: 4.10 ISSN: Heat stable drugs are suitable. MEDICAMENTS REQUIRED FOR PREPARATION OF MEDICATED LOLLIPOPS 4 Drugs candidates which can be incorporated in lollipops belong to one of the following categories. Preparation of Lollipop 1 :- It was planned to prepare candy based lollipops by heating and congealing method using specific polymer. Step-1: The desired quantity of sugar was dissolved in water by heating and stirring in a copper kettle until sugar was completely dissolved. Corn syrup was added when the cooking temperature reaches 110ºC. Cooking was then continued to ºC till the syrupy base becomes thick. Step-2: The finished cooked syrup (154.4ºC) was then pl aced in vacuum chamber which was maintained at 274 mm Hg for about 30 minutes to remove the traces of water molecules and to give plasticity to the base prepared Step-3: The candy base was then transferred to a water-jacketed stainless steel cooling table of 214 ft. for the mixing operation. This mixing was done manually. During the mixing cycle, the temperature of candy base (154ºC) was brought to 90ºC to form a solidified mass. A

4 Impact factor: 3.958/ICV: 4.10 ISSN: hydrogenated vegetable oil-based lubricant was spread onto the table surface to alleviate this condition. At this stage the Drug, polymers, citric acid, other excipients such as Sweetening agents, flavoring agents were added manually and mixed thoroughly. Step-4: Then this solidified mass was poured in Calibrated mould. Step- 5: formation of the individual Lollipop Step-6: The product (Lollipops) placed on the desecrator.then the dried Lollipops is then taken in other container and lubricated with oils so that prepared Lozenges should not stick to each other. Step-7: The prepared lozenges were packed in the aluminium foil. Formulation of medicated lollipop 3 :- Ingredients Examples i) Candy base a. Sugar : Dextrose, sucrose, maltose, lactose. b. Sugar free vehicles : Mannitol, sorbitol, polyethylene glycol (PEG) 600 sand 800. c. Fillers: Di calcium phosphate, calcium sulfate, calcium carbonate, lactose, microcrystalline cellulose. ii) Lubricants : Magnesium stearate, calcium stearate, stearic acid and PEG, vegetable oils and fats. iii) Binders : Acacia, corn syrup, sugar syrup, gelatin tragacanth and methylcellulose. iv) Coloring agents : Water soluble and lakolene dyes, FD & C colors, orange color paste, red color cubes, etc. v) Flavorings agent : Menthol, eucalyptus oil, spearmint, cherry flavor, etc. vi) Whipping agent : vii) Humectants : Milk protein, egg albumin, gelatin, xanthan gum, starch, pectin, algin and carrageenan. Glycerin, propylene glycol and sorbitol.

5 Impact factor: 3.958/ICV: 4.10 ISSN: EVALUATION TEST OF LOLLIPOP:- 1) Drug-excipient interaction study 5 For studying drug-excipients interaction, prepared lozengeswere subjected for FTIR studies 2) Hardness 1 Hardness indicates the ability of a tablet to withstand mechanical shocks while handling the hardness of the tablets was determined using Monsanto hardness tester. It is expressed in kg/cm2.three tablets were randomly picked and hardness of the tablets was determined 3) Friability(F) 1 Roche Friabilator was used for testing the friability. Twenty tablets were weighed accurately and placed in the tumbling apparatus that revolves at 25 rpm. After 4 min., the tablets were weighed and the percentage loss in tablet weight was Determined..F = Wintial-Wfinal / Wintial 100 4) Thickness and Diameter 1 Thickness and diameter was measured using Vernier Calipers. It was determined by checking the thickness and diameter of ten lollipops of each formulation. The extent to which the thickness of the each lollipops deviated from ± 5% of the standard value was determined. 5) Weight Variation 1 Lollipops were randomly checked to ensure that uniform weight Lollipops were being made. 20 Lollipops formulations, weighed individually and average weight and % weight variation was calculated. The requirements are met if the weights of not more than 2 of the Lollipops differ from the average weight by more than the percentage listed in the accompanying table and no lollipops differs in weight by more than double that percentage. In present total weight of lollipop is 1000 mg. So, as per USP maximum difference allowed will be 10% for each lollipop. 6) Drug Content 1 Lollipops dissolved in 100 ml distil water and sonicated for 30 min and filtered. From the above solution 1 ml was taken in volumetric flask and diluted up to 10 ml (100μg/ml) and it was analyzed spectrophotometrically at 224 nm. 7) Moisture Content 1 The sample was weighed and crushed in a mortar. From this, one gram of the sample was weighed and placed in desiccators for 24 hours. After 24 hours the sample is weighed. The moisture content is determined by the abstracting the final weight from initial weight of lollipops.

6 Impact factor: 3.958/ICV: 4.10 ISSN: ) Disintegration Test 1 Disintegration study performed by disintegration apparatus. Put one Lollipop into each tube suspend the assembly in the beaker containing ph 6.8 phosphate buffer and operate without the discs 30 min. Remove the assembly from the liquid. The lollipops pass. 9) In Vitro Drug Release 1 In vitro release studies were performed using USP Apparatus II (Paddle type). The dissolution test was performed using 900 ml of phosphate buffer (ph 6.8), 37 ± 0.5 C, 50 rpm. Samples (5 ml) were collected at predetermined time intervals and replaced with equal volume of fresh medium, and analyzed using UV-Visible spectrophotometer at λ= 224 nm. Drug concentration was calculated from a standard calibration plot and expressed as cumulative % drug release 10) Anti Microbial Assay mg of the polymer sample were separately aseptically mixed with 9 ml of sterile normal saline and the PH was adjusted to 7. 1ml of each dispersion was mixed with 20 ml of sterile lactose broth and placed separately in Petri dish. And the plates were incubated at 37±1oC for 24 hr. After incubation period the samples were observed for the presence of micro flora 11) Taste Masking Test 1 :- First the 10 health volunteers would be given to taste standard quinine solutions ( mcg/ ml) by swirling the solution in buccal cavity for 30 sec. and spitting out the solution. Volunteers would be asked to rank them on bitterness scale (rank 1-5). After 30 min., these volunteers would be asked to evaluate the taste of( drug )lollipop in the same manner and compare on the same scale 12) Stability Studies 6 :- Stability studies for the lollipops were carried out at 30 C at 65%RH as per ICH-Guidelines (Q1A). For every 45days the parameters like physical appearance, weight variation, hardness, drug content and in-vitro dissolution studies were determine. Some Marketed produt 7 : a) Tootsie Pop :- Traditional Tootsie Pops have been around for over 80 years. Originally, their filling was mainly the popular Tootsie Roll, a type of chewy chocolate candy, they have since released lollies with different fruit flavors, caramel, and candy cane. An iconic bestseller, the Tootsie Pop is one of the most popular lollipops around.

7 Impact factor: 3.958/ICV: 4.10 ISSN: b) Rainbow Swirl Lollipops :- Attractive to the eye, rainbow swirl lollipops come in exciting flavor combinations like strawberry and champagne, tropical mix, and fruit salad. They are ideal as party ornaments and come in many different sizes. Swirl lollipops in two-flavor combinations, for example, strawberry and cream, are also quite popular. c) Xyloburst Sugar Free Lollipops:- come in assorted flavors that Xylitol for sweetener. Dentists endorse these lollipops that have natural flavors and healthy ingredients, like beet juice, alfalfa, and citric acid. They are ideal for diabetic children and adults, as well as for anyone looking to cut down on sugar. d) Yummy Earth Vitamin C Lollipops:- Yummy Earth Vitamin C Lollipops are very tasty, and they have the advantage of offering a great nutritious value. When kids are not getting enough Vitamin C from their regular diet, these fun, organic lollipops can be a great supplement. a) b) b) d)

8 Impact factor: 3.958/ICV: 4.10 ISSN: CONLUSION 3 The formulation of medicated lollipop is an easy and time saving process. It is a formulation which is more organoleptically accepted particularly by the pediatrics patients. Medicated Lollipop will be ideal dosage forms for pediatric patients. These will have additional advantages of patient compliance, convenience and comfortness for efficient treatment including low dose, immediate onset of action, reduced dosage regimen and economic. This will offer better innovative dosage form. Medicated lollipop enjoy an important position in pharmacy and will continue to remain at the same in future. REFERENCES 1..M. Prathap*1, Dr. Subhranshu Panda2 and A. Anusha3,Department of Pharmaceutics, Vikas College of Pharmacy, Vissannapeta, Formulation and Evaluation of the Suckable Chewable Medicated Lollipops of Venlafaxine Hcl, World Journal of Pharmaceutical Research Volume 5, Issue 01, Gupta VR, Halakatti PK, Lakshmi MN. Mouth dissolving tablets an innovative 3. Suchita pundir *,Abhay Murari Lal Verma,GRD Institute of Management And Technology,Department of Pharmacy,Rajpur Road, Dehraduan.Review Article on Lozenges,Journal der Pharmazie Forschung Vol-2:No-1: 1-10: Perumalla Jagadeesh*, Padmasetty Jyothi, G. Nethra Vani and S. Dasthagiri Department of Pharmaceutics, Sri Lakshmi Venkateswara Institute of Pharmaceutical Sciences, Proddatur. Review of Medicated Lollipops, WJPR Volume 6, Issue 3, Soumya D, Dharamjit P. Formulation development and optimization of medicated lozenges for paediatric use. Int J Pharm Sci Res 2012; 3(1) : Purushotham RK, Ashok KC, Afshanlaheji, Anilkumar KB, Manjunath P, Baburao NC. Formulation and evaluation of anti-asthmatic theophylline tablet lozenges. Int J Pharm Sci 2011; 3(1) :